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European Union Veterinary legislation Animal Health and Food Safety Control. MVDr. Josef Holejšovský, Ph.D. Institut of Tropics and Subtropics Czech University of Life Sciences Prague. European Union and Veterinary Legislation. Developpment of Cmmunity Veterinary Legislatin.
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European UnionVeterinary legislationAnimal Health andFood Safety Control MVDr. Josef Holejšovský, Ph.D. Institut of Tropics and Subtropics Czech University of Life Sciences Prague
European Unionand Veterinary Legislation Developpment of Cmmunity Veterinary Legislatin
Developpment of EUVeterinary Legislation 1. In 1957 the Rome Treaty signed and the EEC created 2.Common Agar Policy became the most important issue regarding the food supplyindependence 3.Differences in veterinary policy caused by different animal health status 4.Different veterinary policy – obstacles for free movement i.e. for single market of animals and animal's origin product.
Developpment of EUVeterinary Legislation 5.In 1964 first veterinary directives adopted- Council Directives64/432 and 64/433/EEC laing down requirements concerning animal healths and and food safety for intacommunity trade (placing on the community market). 6. In 1972 further directive adopted i.e. CD 72/462/EEC covering the same areas while trading with third countries
Developpment ofEU Veterinary Legislation 7. In 1987 – European Single Market Act- the most productive period as for theVeterinary legislation began. 8. In 1988Strategic Document – basis for preparation of veterinary legislation leading towards full harmonisation till the end of 1992 (Mastricht Treaty on EU) .
Main Points of Strategic Document: • full harmonizationof veterinary legislaton • over the whole territory of • EU Member States • the same status as for the animal and • public health in all MS at highest level • possible • clasification of diseases in compliance • with their importance for animal and • human health • new systeme of control and supervision • new health safety definition- principle • of regionalization
The European Court ofJustice The European Commission The European Parliament European Investment Bank Institutions of the European Union involved in Legal Process Goal Goal The Council of the European Union EuropeanCourt ofauditors Economic and Social Committee Committee of theRegions European Ombudsman
Institutions of the European UnionInvolved in Legal Process The Council of the European Union represents the EU member states The European Parliament represents the EU citizens The European Commission represents the EU as a whole
The EU Legislative Process . • Initiative • Consultation • Decision making EuropeanParliament Council of Ministers EuropeanCommission
Legal Instruments • Regulation • directly applicableand binding on all Member States (MS) • Directive • Transposed in to the national legislation MS must adopt national measuresto meet its objectives (to achieve the same effect) • Decisions • binding on thoseto whom it is addressed
European Union Food LegislationFood Hygiene17 Directives 64/433 71/118 72/461 77/96 77/99 80/215 89/362 89/437 91/492 91/493 91/494 91/495 92/45 92/46 92/48 94/65 93/43
Which are covering • Egg Products • Bivalve molluscs • Fishery products Fishing vessels • Poultymeat - 3rd • Milk & MilkProduction • Rabbit and game • Wild game • Hygiene offoodstuffs • Fresh meat • Fresh Poultrymeat • Fresh meat • Pigmeat 3rCountries • Meat Products • Animal Health/meat • Minced Meat
Developpement of the New EU Food Legislation FromGreen Papertowards the Food Law • Green Paper – 1997 • Presents Food Safety Issues to Citizens and Institutions for public discussion White Paperon Food Safety - 2000 • Defined Food Safety Policy and its Principles based on Discussion Results iniciated ba Green Paper • General Foodlaw(2002) – Regulation (EC) 178/2002 • Lays down leagally Food Safety Poicy Principles andestablishes EFSA • European Food Safety Authority – EFSA • Carries out risk assesment and risk analysis on scientific basis
Green Paperof the EU • Foccused : • On Food Legislation • On its Comprehancivness • On Lacks and Shortcommings in Food Legislation, Transparency and Consistency • Identifies Nonharmonized Legislation Areas leading to Trade Barriers • Identifies implementation and interpretation differencieson national level
THE WHITE PAPERON FOOD SAFETY • Global comprehensive approach • wholefeed and foodchain • all feed and food • Clear division of responsibilities • traceability/withdrawalof food • risk analysis • precautionaryprinciple
New legal framework • General Food Law178/2002/EC • Hygiene Package852 and 853, /2004/EC • Offical Feed and Food Controls and Auditss854/2004/EC, 882/2004/EC All involved for import into the EU
European Union and Veterinary Legislation New EU Food Legislation
Regulation (EC) 178/2002EU GENERAL FOOD LAW • Article 1 Aim and Scope • This Regulation lays down the general principles governing food and feed in general, and food and feed safety in particular, at Community and national level. • It establishes the European Food Safety Authority. • It lays down procedures for matters with a direct or indirect impact on food and feed safety.
Regulation (EC) 178/2002 • Article 1 Aim and Scope (2) • This Regulation shall apply to all stages of production, processing and distribution of food and feed. • It shall not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption.
Regulation (EC) 178/2002 • Article 3 Other definitions • 1. ‘food law’ means the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals; • 2. ‘food business’ means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food; • 3. ‘food business operator’ means the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control;
Regulation (EC) 178/2002 • Article 3 other definitions • 7. ‘retail’means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets; • 8. ‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves;
Regulation (EC) 178/2002 • Article 3 other definitions • 9. ‘risk’means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard; • 10. ‘risk analysis’ means a process consisting of three interconnected components: risk assessment, risk management and risk communication; • 11. ‘risk assessment’ means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation; • 12. ‘risk management’ means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options; • 13. ‘risk communication’ means the interactive exchange of information and opinions throughout the risk analysis process as regards hazards and risks, risk-related factorsand risk perceptions, among risk assessors, risk managers,consumers, feed and food businesses, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions;
Risk • Probability of a hazard • (Likelihood of occurrence) • Severity of hazard • (What type of effects if it does occur) • Risk perception
Risk Analysis • Risk Assessment:provides a scientific foundation for risk management and design food security plan • Risk Management:practical and effective food safety practices • Risk Communication:promotes communication, awareness, understanding and ownership of the Risk Assessment process and outcomes
Risk Assessment Outputs • Risk Ranking of priority hazards • Significant hazards • Severity • Risk Estimate • Likelihood of occurrence • Justification of risk assignment • Scientific basis • Control options • Preventive measures
Basic Principles • Integrating risk management into food security planning, preparation and execution • Making risk decisions at the appropriate level • Accepting no unnecessary risk
Risk Communication • To employees • To media • To public
The Components of Risk Analysis Risk Analysis Risk Assessment Scientifically Based Risk Assessment Risk Communication Risk Communication Risk Management Legally based
Regulation (EC) 178/2002 • Article 3 other definitions • 14. ‘hazard’ means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect; • 15. ‘traceability’ means the ability to trace and follow a food, feed, food-producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution; • 16. ‘stagesof production, processing and distribution’ means any stage,including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the importation, production, manufacture, storage, transport, distribution, sale and supply of feed;
Regulation (EC) 178/2002 • Article 14 Food safety requirements • 1. Food shall not be placed on the market if it is unsafe. • 2. Food shall be deemed to be unsafe if it is considered to be: • (a) injurious to health; (wholesomness) • (b) unfit for human consumption.
Regulation (EC) 178/2002 • Article 14 Food safety requirements • 3. In determining whether any food is unsafe, regard shall be had: • (a) to the normal conditions of use of the food by the consumer and at each stage of production, processing and distribution, and • (b) to the information provided to the consumer, including information on the label, or other information generally available to the consumer concerning the avoidance of specific adverse health effects from a particular food or category of foods.
Regulation (EC) 178/2002 Reg. 178/2002 – EU GENERAL FOOD LAW lays down principles of EU Food Law • Unsafe food must not be placed on market • Applies to all food chain including farmers. • Applies to agricultural inputs e.g. animal feed • Feed traceability highlighted • Food business operator primary responsibility for safety of foodproduced • Based onEU„Precautionary Principle“ x WTO
Regulation (EC) 178/2002EU Food safety policy Goal To ensure: • a high level of protectionof • human health and • consumers' interestin relation to food, • taking into account • diversity, including • traditional products, whilst ensuring the effective functioning of the internal market.
Regulation (EC) 178/2002Food SafetyBasic principles • Scientific Risk Assessmentseparation from Risk Management • European Food Safety Authority (EFSA) • European Commission DG SANCO • Transparency and Public Participation • Rapid Alert System • Advisory Group on the Food Chain, Animal and Plant Health
Regulation (EC) 178/2002Food hygiene basic principles • Simplification • Create uniform procedures (e.g. HACCP, imports) • Create single framework for all food • Separation of responsibilities • Prime responsibility with operators • Competent authority verifies compliance
Food and Feed Producers obligations(1) • Safety Operators shall not place on the marketunsafe food or feed • Responsibility Operatorsare responsible for the safetyof the food and feedwhich they produce, transport, store or sell • Traceability Operators shall be able to rapidly identify any supplier or consignee
Food and FeedProducers obligations (2) • Transparency Operatorsshall immediately inform the competent authorities if they have a reason to believe that their food or feed is not safe • Emergency Operatorsshall immediately withdraw food or feed from the market if they have a reason to believe that it is not safe
Food and Feed Producers obligations (3) • Prevention Operators shall identify and regularly review the critical points in their processes and ensure that controls are applied at these points • Co-operation Operators shall co-operate with the competent authorities in actions taken to reduce risks
Regulation 852/2004/ECon Food Hygiene Introduces GeneralHygienic principles and requirements for all food (of plant and animal origin)
Regulation 852/2004/ECLegal provisions • Article 1 Scope • 1. This Regulation lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the following principles: • (a) primary responsibility for food safety rests with the food business operator; • (b) it is necessary to ensure food safety throughout the food chain, starting with primary production; • (c) it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain;
Regulation 852/2004/ECLegal provisions • Article 1 Scope (1) • (d) general implementation of procedures based on the HACCP principles, together with the application of Good Hygiene Practice, should reinforce food business operators' responsibility; • (e) guides to good practice are a valuable instrument to aid food business operators at all levels of the food chain with compliance with food hygiene rules and with the application of the HACCP principles;
Regulation 852/2004/ECLegal provisions • Article 1 Scope (2) • (f) it is necessary to establish microbiological criteria and temperature control requirements based on a scientific risk assessment; • (g) it is necessary to ensure that imported foods are of at least the same hygiene standard as food produced in the Community, or are of an equivalent standard. • This Regulation shall apply to all stages of production, processing and distribution of food and to exports, and without prejudice to more specific requirements relating to food hygiene.
Regulation 852/2004/ECLegal provisions • Article 1 Scope (3) • 2. This Regulation shall not apply to: • (a) primary production for private domestic use; • (b) the domestic preparation, handling or storage of food for private domestic consumption;
Regulation 852/2004/ECLegal provisions • Article 1 Scope (4) • (c)the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer; • (d) collection centres and tanneries which fall within the definition of food business only because they handle raw material for the production of gelatine or collagen.
Regulation 852/2004/ECLegal provisions • Article 1 Scope (5) • 3. Member States shall establish, under national law, rules governing the activities referred to in paragraph 2(c). Such national rules shall ensure the achievement of the objectives of this Regulation.
Regulation 852/2004/ECLegal provisions • ANNEX I PRIMARY PRODUCTION • PART A: GENERAL HYGIENE PROVISIONS FOR PRIMARY PRODUCTION AND ASSOCIATED OPERATIONS • III. Record-keeping • 7. Food business operators are to keep and retain records relating to measures put in place to control hazards in an appropriate manner and for an appropriate period, commensurate with the nature and size of the food business. • Food business operators are to make relevant information contained in these records available to the competent authority and receiving food business operators on request.
Regulation 852/2004/ECGeneral principles • Farm-to-table • Primary production • HACCP based procedures • Microbiological criteria • Registration of food businesses • Guides togood practice • Flexibility (traditional production, processing and distribution) • Technical requirements
Regulation 852/2004/ECPrimary productionGeneral rules • Protection against contamination • Compliance with rules to control hazards • Cleanliness, use of water, use of medicinal products, pesticides etc, • Record keeping • Guides togood practice
Regulation 852/2004/ECHACCP • Procedure based on the HACCPprinciples • Arrangements to facilitateimplementation by certain food businesses • Objective = control hazards • Prerequisite requirements • CriticalControlPoints • Guides to good practice • Documents and records
HACCP and Food Safety What is HACCP? • Proven method used to ensure the safety of the foods„Systém in the Control Activities“ • Originally developed for NASA space flights • Systematic approach that ensures food safety by looking at all processes as food “flows” throughthe processing plant